CLASS II Device recall · Reported 16 Sep 2020 · FDA Enforcement Report

Merge PACS recalled by Merge Healthcare

Merge Healthcare is recalling Merge PACS, distributed in 25 states. The recall was initiated on 6 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUnique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1: PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528 V8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709

Quantity recalled125 total units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2944-2020
FDA event ID: 86205
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2020
FDA classified: 9 Sep 2020
Reported: 16 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Aug 2020	Recall initiated by company
9 Sep 2020	Classified by FDA	+34 days
16 Sep 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

Product as listed by the FDA

Merge PACS

Where it was distributed

Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.

Arkansas California Connecticut Delaware Florida Georgia Illinois Indiana Maryland Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Hampshire New Mexico New York Ohio

Questions about this recall

Why was it recalled?

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

Which lots are affected?

Unique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1: PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528 V8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709

Where was it sold?

Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Merge Healthcare

All 96

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
12 Aug 2026Device	CLASS II	Merge OrthoPACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
12 Aug 2026Device	CLASS II	Merge PACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
10 Sep 2025Device	CLASS II	The Merge Hemo recalled by Merge Healthcare	Merge Healthcare	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Vericis, Merge Cardio recalled by Merge Healthcare	Merge Healthcare	Device Malfunction	WI

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